NCT01217112

GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes

A Randomised, Double Blind, Placebo Controlled, Parallel Group, Pilot Study of 1:1 and 20:1 Ratio of Formulated GWP42003 : GWP42004 Plus GWP42003 and GWP42004 Alone in the Treatment of Dyslipidaemia in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 15-19 week study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two cannabinoids: GWP42004 and GWP42003 alone, or in combination in patients with Type 2 diabetes. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight, liver fat content and other metabolic parameters compared with a placebo medication.

Detailed description

In this study there was a 1-5 week baseline period followed by a 13 week treatment period, and a one week follow-up. Eligible subjects entered the study at a screening visit (Visit 1) before returning for randomisation (Visit 2, Day 1). At the discretion of the investigator (based on individual subjects), Visit 1 could be split into two separate visits (Visits 1A and B) to allow a 21-day washout period of prohibited medications prior to blood sampling for eligibility. Further outpatient study visits (for assessment purposes) took place at the study site at the end of Week 4 of treatment (Visit 3, Day 29), and at the overall end of treatment at Week 13 (Visit 5, Day 92). A telephone assessment was also performed at Day 57 (Visit 4) and at Week 14 (Visit 6, Day 99) for safety follow-up purposes. During the 13 week randomised treatment phase, subjects received blinded, oral doses of their allocated randomised treatment twice daily. Treatment was self-administered on an outpatient basis, once in the morning and once in the evening for 13 weeks. Subjects were instructed to time study medication to 30 minutes before breakfast and evening meals. Physical and metabolic parameters were assessed before, during and after treatment to evaluate clinical response. Diabetic and dyslipidaemic medication usage (where applicable), and appetite 0-10 NRS data were collected daily during the treatment period, using the study diary.

Conditions

• Dyslipidemias
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	GWP42003	100 mg capsules, PO, BD, 91 days
DRUG	GWP42003	5 mg capsules, PO, BD, 91 days
DRUG	GWP42004	5 mg capsules, PO, BD, 91 days
DRUG	Placebo	0 mg capsules, QDS, PO, 91 days

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-05-01
• Completion: 2012-09-01
• First posted: 2010-10-08
• Last updated: 2022-10-18
• Results posted: 2014-01-20

Locations

5 sites across 1 country: United Kingdom